NCT01269489

Brief Summary

The purpose of the study is to obtain reference data on health-related quality of life for the functional and symptom scales and single items of the European Organisation for Research and Treatment of Cancer Core Quality-of-Life Questionnaire (EORTC QLQ C30) in a representative sample of Slovenian general population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 26, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

January 1, 2011

Last Update Submit

March 23, 2012

Conditions

Health-related Quality of Life

Keywords

quality of lifegeneral Slovenian populationEORTC QLQ C30

Study Arms (1)

general population

a representative sample from general Slovenian population

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

sample from general Slovenian population

You may qualify if:

  • age 18 y and more

You may not qualify if:

  • serious comorbidity
  • previously treated for cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (2)

  • Cocks K, King MT, Velikova G, Fayers PM, Brown JM. Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. Eur J Cancer. 2008 Sep;44(13):1793-8. doi: 10.1016/j.ejca.2008.05.008. Epub 2008 Jul 1.

    PMID: 18599286BACKGROUND

  • Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.

    PMID: 11858978BACKGROUND

Study Officials

  • Vaneja Velenik, PhD, MD

    Institute of Oncology Ljubljana Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vaneja Velenik, PhD,MD

CONTACT

+38615879661vvelenik@onko-i.si

Vesna Zadnik, PhD,MD

CONTACT

+38615879661vzadnik@onko-i.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 1, 2011

First Posted

January 4, 2011

Study Start

December 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 26, 2012

Record last verified: 2012-03

Locations

SL(1)